HydroVax-001B Vaccine for West Nile Virus

Not currently recruiting at 1 trial location
SL
Overseen BySarah L George
Age: 18 - 65
Sex: Any
Trial Phase: Phase 1
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to find a safe and effective vaccine to prevent West Nile virus infection, a disease spread by mosquito bites. Researchers are testing different doses of the HydroVax-001B vaccine to evaluate its efficacy and monitor for any side effects. Participants will receive either the vaccine or a placebo (a harmless inactive substance) and must be healthy adults who have never had a flavivirus infection or vaccine. This study is ideal for those in good health without recent serious medical issues.

As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new vaccine.

Will I have to stop taking my current medications?

The trial protocol does not specify if you must stop taking your current medications. However, if you have started a new prescription medication within 30 days of enrollment, it may affect your eligibility unless it's in the same class or a brand/generic switch. Also, certain medications that could pose a risk or interfere with the study might require adjustment.

Is there any evidence suggesting that the HydroVax-001B WNV vaccine is likely to be safe for humans?

Research has shown that the HydroVax-001 vaccine, similar to HydroVax-001B, is safe and well-tolerated in previous studies. These studies reported no serious side effects at the 1 mcg dose, indicating that the vaccine does not cause major side effects at lower doses. The current trial, in its early stages, aims to assess the safety of HydroVax-001B at higher doses of 4 mcg and 10 mcg to ensure it remains safe for participants.12345

Why do researchers think this study treatment might be promising?

Researchers are excited about the HydroVax-001B vaccine for West Nile Virus because it introduces a potentially powerful new way to prevent the disease. Unlike current treatments, which primarily focus on managing symptoms or providing supportive care, HydroVax-001B aims to protect against the virus itself through immunization. This vaccine uses a novel formulation that could offer better protection with both low and high dose options. The ability to administer it intramuscularly at specific intervals (Day 1, Day 29, and Day 181) may also enhance its effectiveness and convenience compared to existing options.

What evidence suggests that the HydroVax-001B WNV vaccine might be an effective treatment for West Nile Virus?

Research shows that the HydroVax-001B vaccine for West Nile Virus (WNV) effectively creates a strong immune response. It helps the body produce antibodies that fight infections, particularly effective against certain virus strains. Studies have found that the vaccine is well-tolerated, meaning it does not cause serious side effects. Early results suggest that the vaccine could play a crucial role in preventing WNV infections and reducing related health problems. Overall, these findings indicate that HydroVax-001B is a promising option for protection against West Nile Virus.16789

Are You a Good Fit for This Trial?

Healthy adults aged 18-49 who can follow the study plan and attend all visits. They must consent to blood collection and not be pregnant or breastfeeding. Those with previous flavivirus infections, vaccinations, or likely exposure are excluded.

Inclusion Criteria

Oral temperature is less than 100.4 degrees Fahrenheit at screening
Pulse is 51 to 100 beats per minute, inclusive at screening
Systolic blood pressure is 90 to 140 mmHg, inclusive at screening
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Exclusion Criteria

Has history of alcohol or drug abuse within 5 years prior to study vaccination per investigator's discretion
I have diabetes type I or II, or had gestational diabetes that is now resolved.
I have not been hospitalized for psychiatric reasons or posed a danger to myself or others in the last 5 years.
See 27 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the HydroVax-001B WNV vaccine or placebo on Days 1, 29, and 181

26 weeks
3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Long-term follow-up

Participants are monitored for serious adverse events and immunogenicity

13 months

What Are the Treatments Tested in This Trial?

Interventions

  • HydroVax-001B WNV
Trial Overview The trial is testing HydroVax-001B WNV vaccine's safety and ability to provoke an immune response against West Nile Virus in healthy adults compared to a placebo (saltwater). Participants will receive either a low or high dose of the vaccine on specific days.
How Is the Trial Designed?
4Treatment groups
Experimental Treatment
Placebo Group
Group I: Group 1BExperimental Treatment2 Interventions
Group II: Group 1AExperimental Treatment2 Interventions
Group III: Group 2APlacebo Group1 Intervention
Group IV: Group 2BPlacebo Group1 Intervention

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Who Is Running the Clinical Trial?

National Institute of Allergy and Infectious Diseases (NIAID)

Lead Sponsor

Trials
3,361
Recruited
5,516,000+

Published Research Related to This Trial

A novel adenoviral vaccine (CAdVax) was developed that successfully induced both humoral (antibody) and cellular immune responses in mice against West Nile Virus (WNV), suggesting its potential as an effective vaccine.
The vaccine generated broadly neutralizing antibodies against both genetic lineages of WNV, particularly showing strong effectiveness against lineage II, indicating that a multiantigen approach could offer comprehensive protection against various WNV strains.
Complex adenovirus-mediated expression of West Nile virus C, PreM, E, and NS1 proteins induces both humoral and cellular immune responses.Schepp-Berglind, J., Luo, M., Wang, D., et al.[2019]
The HydroVax-001WNV vaccine, developed using a hydrogen peroxide-inactivated whole virion approach, showed strong immune responses and protection against West Nile virus in both mice and rhesus macaques, indicating its potential efficacy.
A toxicology study in rats revealed an excellent safety profile for the vaccine, with only minor and temporary irritation at the injection site, and stability tests showed no loss of efficacy over six months under various storage conditions.
Pre-clinical development of a hydrogen peroxide-inactivated West Nile virus vaccine.Poore, EA., Slifka, DK., Raué, HP., et al.[2020]
The WN-VAX vaccine, derived from the West Nile Virus-NY99 strain, demonstrated 100% efficacy in protecting 4-week-old mice from lethal WNV challenges after two doses, even at a very low dilution of 3.2 ng/dose.
Safety tests showed no short- or long-term adverse effects in experimental animals or cell lines, indicating that WN-VAX is safe and ready for planned human trials in Japan.
Development and evaluation of a formalin-inactivated West Nile Virus vaccine (WN-VAX) for a human vaccine candidate.Posadas-Herrera, G., Inoue, S., Fuke, I., et al.[2019]

Citations

Safety and Immunogenicity of an Inactivated West Nile ...The secondary objective is to assess immunogenicity of 4 mcg versus 10 mcg dose of HydroVax-001B WNV vaccine given IM on Days 1, 29 and 181 as measured by WNV- ...
An observer blinded, randomized, placebo-controlled ...Conclusions. The HydroVax-001 WNV vaccine was found to be modestly immunogenic and welltolerated at all dose levels.
HydroVax-001B Vaccine for West Nile VirusThe vaccine generated broadly neutralizing antibodies against both genetic lineages of WNV, particularly showing strong effectiveness against lineage II, ...
Combating West Nile Virus Disease — Time to Revisit ...WNV vaccination would be more effective in preventing WNV disease and related deaths. Lessons from the development of other vaccines can be ...
Pre-clinical development of a hydrogen peroxide ...Together, the positive pre-clinical findings regarding immunogenicity, safety, and stability indicate that HydroVax-001 WNV is a promising vaccine candidate.
VaccineHydroVax-001 was safe and well-tolerated as there were no serious adverse events or concerning safety signals. At the 1 mcg dose, HydroVax-001 was not ...
IDCRC launches clinical trail to study the safety and ...This trial will assess the safety and immunogenicity of the second-generation HydroVax-001B WNV vaccine, produced by Najit Techonolgies, Inc., ...
West Nile virus vaccines – current situation and future directionsFirstly, two doses of a hydrogen peroxide inactivated WNV vaccine led to detectable neutralizing antibodies in approx. 50% of the study participants. The ...
An observer blinded, randomized, placebo-controlled, phase I ...RESULTS: HydroVax-001 was safe and well-tolerated as there were no serious adverse events or concerning safety signals. At the 1 mcg dose, HydroVax-001 was not ...
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